Vắc-xin COVID-19: sự phát triển nhanh chóng, hệ lụy, thách thức và triển vọng tương lai
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Gupta A, Kashte S, Gupta M, Rodriguez HC, Gautam SS. Mesenchymal stem cells and exosome therapy for COVID-19: current status and future perspective. Hum Cell. 2020;33:907–18. https://doi.org/10.1007/s13577-020-00407-w.
WHO Coronavirus Disease (COVID-19) Dashboard [Internet]. WHO (World Heal. Organ. 2021. Available from: https://covid19.who.int/. Cited 3 Jan 2021.
Khuroo MS. Chloroquine and hydroxychloroquine in coronavirus disease 2019 (COVID-19). Facts, fiction and the hype: a critical appraisal. Int J Antimicrob Agents. 2020;56:106101.
Draft Landscape of COVID-19 candidate vaccines—29 December 2020 [Internet]. World Heal. Organ. 2020, p. 12. Available from: www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines. Cited 30 Dec 2020.
Dai X, Xiong Y, Li N, Jian C. Vaccine types. In; Vaccines-the history and future. IntechOpen. 2001, pp 1–9.
Khuroo MS, Khuroo M, Khuroo MS, Sofi AA, Khuroo NS. COVID-19 vaccines: a race against time in the middle of death and devastation. J Clin Exp Hepatol. 2020. https://doi.org/10.1016/j.jceh.2020.06.003.
Kaur SP, Gupta V. COVID-19 vaccine: a comprehensive status report. Virus Res. 2020;288:198114. https://doi.org/10.1016/j.virusres.2020.198114.
Ou X, Liu Y, Lei X, Li P, Mi D, Ren L, et al. Characterization of spike glycoprotein of SARS-CoV-2 on virus entry and its immune cross-reactivity with SARS-CoV. Nat Commun. 2019;11:1620. https://doi.org/10.1038/s41467-020-15562-9.
Cunningham AL, Garçon N, Leo O, Friedland LR, Strugnell R, Laupèze B, et al. Vaccine development: from concept to early clinical testing. Vaccine. 2016;34:6655–64. https://doi.org/10.1016/j.vaccine.2016.10.016.
Krammer F. SARS-CoV-2 vaccines in development. Nature. 2020;586:516–27. https://doi.org/10.1038/s41586-020-2798-3.
Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry [Internet]. Food Drug Adm. 2020. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19. Cited 14 Dec 2020.
Pallesen J, Wang N, Corbett KS, Wrapp D, Kirchdoerfer RN. Immunogenicity and structures of a rationally designed prefusion MERS-CoV spike antigen. Proc Natl Acad Sci. 2017;114:E7348–57.
FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine [Internet]. FDA. 2020. Available from: https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19. Cited 15 Dec 2020.
WHO issues its first emergency use validation for a COVID-19 vaccine and emphasizes need for equitable global access [Internet]. World Health Organ. Available from: www.who.int/news/item/31–12–2020-who-issues-its-first-emergency-use-validation-for-a-covid-19-vaccine-and-emphasizes-need-for-equitable-global-access. Cited 01 Jan 2021.
Pfizer. Aa phase 1/2/3, placebo-controlled, randomized, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and efficacy of sars-cov-2 rna vaccine candidates against covid-19 in healthy individuals. 2020. p 1–146. https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf.
Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, et al. Safety and immunogenicity of two RNA-based covid-19 vaccine candidates. N Engl J Med. 2020;383:2439–50.
Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Phase I / II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. 2020;586:589–93. https://doi.org/10.1038/s41586-020-2639-4.
Holm M, Poland G. Critical aspects of packaging, storage, preparation, and administration of mRNA and adenovirus-vectored COVID-19 vaccines for optimal efficacy. Vaccine. 2020. https://doi.org/10.1016/j.vaccine.2020.12.017.
Moderna’s COVID-19 vaccine candidate meets its primary efficacy endpoint in the first interim analysis of the phase 3 COVE study [Internet]. 2020. Available from: https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy. Cited 17 Nov 2020.
Coler RN, Mccullough MP, Chappell JD, Denison MR, Stevens LJ, Morabito KM, et al. An mRNA vaccine against SARS-CoV-2 — preliminary report. N Engl J Med. 2020;383:1920–31.
Makhene M, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, Mcdermott AB, et al. Safety and immunogenicity of SARS-CoV-2 mRNA-1273 vaccine in older adults. N Engl J Med 2020;383:2427–38.
Corbett KS, Edwards DK, Leist SR, Abiona OM, Boyoglu-barnum S, Gillespie RA, et al. SARS-CoV-2 mRNA vaccine design enabled by prototype pathogen preparedness. Nature. 2020;586:567–71. https://doi.org/10.1038/s41586-020-2622-0.
Flach B, Connell SO, Bock KW, Minai M, Nagata BM, Andersen H, et al. Evaluation of the mRNA-1273 vaccine against SARS-CoV-2 in nonhuman primates. N Engl J Med. 2020;383:1544–55.
Moderna Announces Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Begins [Internet]. 2020. Available from: https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-phase-3-cove-study-mrna-vaccine-against-covid. Cited 17 Nov 2020.
AstraZeneca’s COVID-19 vaccine authorised for emergency supply in the UK [Internet]. AstraZeneca. Available from: https://www.astrazeneca.com/media-centre/press-releases/2020/astrazenecas-covid-19-vaccine-authorised-in-uk.html. Cited 30 Dec 2020.
India’s drugs experts approve AstraZeneca, local COVID vaccines [Internet]. Reuters. 2021. Available from: https://www.reuters.com/article/health-coronavirus-india-vaccine/indias-drugs-experts-approve-astrazeneca-local-covid-vaccines-idUSKBN29707B. Cited 3 Jan 2021.
Doremalen N Van, Lambe T, Spencer A, Belij-rammerstorfer S, Purushotham JN, Port JR, et al. ChAdOx1 nCoV-19 vaccination prevents SARS-CoV-2 pneumonia in rhesus macaques. Nature. 2020;586:578–82.
Graham SP, Mclean RK, Spencer AJ, Belij-Rammerstorfer S, Wright D, Ulaszewska M, et al. Evaluation of the immunogenicity of prime-boost vaccination with the replication-deficient viral vectored COVID-19 vaccine candidate ChAdOx1 nCoV-19. NPJ Vaccines. 2020;5:1–6. https://doi.org/10.1038/s41541-020-00221-3.
Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-rammerstorfer S, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1 / 2, single-blind, randomised controlled trial. Lancet. 2020;396:467–78.
Clinical study protocol - amendment 2 AZD1222 - D8110C00001. A phase III randomized, double-blind, placebo-controlled multicenter study in adults to determine the safety, efficacy, and immunogenicity of AZD1222, a non-replicating ChAdOx1 vector vaccine, for the prevention of COVID-19. AstraZeneca. 2020. p. 1–111. https://astrazenecagrouptrials.pharmacm.com/ST/Submission/View?id=26198.
Sinovac’s Coronavirus vaccine candidate approved for emergency use in China [Internet]. Reuters. 2020. Available from: https://www.reuters.com/article/us-health-coronavirus-china-vaccines/sinovacs-coronavirus-vaccine-candidate-approved-for-emergency-use-in-china-source-idUSKBN25O0Z3. Cited 15 Dec 2020.
Gao Q, Bao L, Mao H, Wang L, Xu K, Yang M, et al. Development of an inactivated vaccine candidate for SARS-CoV-2. Science. 2020;81:77–81.
Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years. Lancet Infect Dis. 2020. https://doi.org/10.1016/S1473-3099(20)30843-4.
Brazil’s National Health Surveillance Agency Authorizes Resumption of the Phase III Clinical Trial of CoronaVacTM [Internet]. 2020. Available from: http://www.sinovac.com/?optionid=754&auto_id=915. Cited 18 Nov 2020.
Taylor A. China’s COVID vaccines are already being distributed. But how do they work, and where are they up to in trials? [Internet]. Conversat. 2020. Available from: https://theconversation.com/chinas-covid-vaccines-are-already-being-distributed-but-how-do-they-work-and-where-are-they-up-to-in-trials-151589. Cited 15 Dec 2020.
Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, Yang Y. Effect of an inactivated vaccine against SARS-CoV-2 on safety and immunogenicity outcomes interim analysis of 2 randomized clinical trials. JAMA. 2020;324:951–60.
Babira VF, Borisevich SV, Naroditsky BS, Gintsburg AL. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020;396:887–97. https://doi.org/10.1016/S0140-6736(20)31866-3.
Sputnik V. The first registered vaccine against COVID-19. [Internet]. 2020. Available from: https://sputnikvaccine.com/about-vaccine/. Cited 19 Nov 2020.
Wang H, Zhang Y, Huang B, Gao GF, Tan W, Yang X. Development of an inactivated vaccine candidate, BBIBP-CorV, with potent protection against SARS-ll article development of an inactivated vaccine candidate, BBIBP-CorV, with potent protection against SARS-CoV-2. Cell. 2020;182:713–21.
Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect Dis. 2020. https://doi.org/10.1016/S1473-3099(20)30831-8.
Russia approves second COVID-19 vaccine after preliminary trials [Internet]. Reuters. 2020. Available from: https://in.reuters.com/article/us-health-coronavirus-russia-vaccine-idINKBN26Z1T3. Cited 15 Dec 2020.
Russia begins mass trials of second coronavirus vaccine [Internet]. Reuters. 2020. Available from: https://www.reuters.com/article/health-coronavirus-russia-cases/update-1-russia-begins-mass-trials-of-second-coronavirus-vaccine-idUSL1N2IG0HG?edition-redirect=ca. Cited 15 Dec 2020.
Yadav P, Mohandas S. Remarkable immunogenicity and protective e cacy of BBV152 , an inactivated SARS-CoV-2 vaccine in rhesus macaques [Internet]. Res. Sq. 2020. p. 1–17. Available from: https://www.researchsquare.com/article/rs-65715/v1. Cited 19 Nov 2020.
COVAXINTM—India’s First indigenous COVID-19 Vaccine [Internet]. 2020. Available from: https://www.bharatbiotech.com/covaxin.html. Cited 18 Nov 2020.
Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen’s COVID-19 Vaccine Candidate [Internet]. 2020. Available from: https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate. Cited 20 Nov 2020.
Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, Berghmans PJ. Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results 2 of a phase 1/2a, double-blind, randomized, placebo-controlled trial. MedRxiv. 2020;94:1–28.
Tostanoski LH, He X, Martinez DR, Rutten L, Bos R, Van MD, et al. Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques. Nature. 2020;586:583–8. https://doi.org/10.1038/s41586-020-2607-z.
Tostanoski LH, Wegmann F, Martinot AJ, Loos C, Mcmahan K, Mercado NB, et al. Ad26 vaccine protects against SARS-CoV-2 severe clinical disease in hamsters. Nat Med. 2020;26:1694–700. https://doi.org/10.1038/s41591-020-1070-6.
Novavax Awarded Funding from CEPI for COVID-19 Vaccine Development [Internet]. 2020. Available from: https://ir.novavax.com/news-releases/news-release-details/novavax-awarded-funding-cepi-covid-19-vaccine-development. Cited 20 Nov 2020.
Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, et al. Phase 1–2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine. N Engl J Med. 2020;383:1–13.
Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA [Internet]. 2020. Available from: https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-granted-fast-track-designation-us-fda. Cited 20 Nov 2020.
Novavax Provides Phase 3 COVID-19 Vaccine Clinical Development Update [Internet]. 2020. Available from: https://ir.novavax.com/news-releases/news-release-details/novavax-provides-phase-3-covid-19-vaccine-clinical-development. Cited 20 Nov 2020.
COVAX announces additional deals to access promising COVID-19 vaccine candidates; plans global rollout starting Q1 2021 [Internet]. Glob. Alliance Vaccines Immunizations. 2020. Available from: https://www.gavi.org/news/media-room/covax-announces-additional-deals-access-promising-covid-19-vaccine-candidates-plans. Cited 23 Dec 2020.
Craig AM, Hughes BL, Swamy GK. COVID-19 Vaccines in Pregnancy. Am J Obstet Gynecol MFM. 2021. https://doi.org/10.1016/j.ajogmf.2020.100295.
Krubiner CB, Faden RR, Karron RA, Little MO, Lyerly AD, Abramson JS, et al. Pregnant women and vaccines against emerging epidemic threats: ethics guidance for preparedness, research, and response. Vaccine. 2021;39:85–120. https://doi.org/10.1016/j.vaccine.2019.01.011.
Doherty M, Buchy P, Standaert B, Giaquinto C, Cohrs DP. Vaccine impact: benefits for human health. Vaccine. 2016;34:6707–14. https://doi.org/10.1016/j.vaccine.2016.10.025.
Bartsch SM, Shea KJO, Ferguson MC, Bottazzi ME, Wedlock PT, Strych U, et al. Vaccine efficacy needed for a COVID-19 Coronavirus vaccine to prevent or stop an epidemic as the sole intervention. Am J Prev Med. 2020;59:493–503. https://doi.org/10.1016/j.amepre.2020.06.011.
Sharma O, Sultan AA, Ding H, Triggle CR. A review of the progress and challenges of developing a vaccine for COVID-19. Front Immunol. 2021;11:1–17.
Savarino S, Zambrano B, Moureau A, Khromava A, Moodie Z, Westling T, et al. Effect of Dengue serostatus on Dengue vaccine safety and efficacy. N Engl J Med. 2018;379:327–40.
Coronavirus (COVID-19) vaccine [Internet]. NHS. 2020. Available from: https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/. Cited 28 Dec 2020.
What to Expect after Getting a COVID-19 Vaccine [Internet]. Centers Dis. Control Prev. 2020. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html. Cited 28 Dec 2020.
Fact sheet for recipients and caregivers, Emergency Use Authorization (EUA) of the Pfizer-Biontech COVID-19 vaccine to prevent Coronavirus disease 2019 (COVID-19) in individuals 16 years of age and older [Internet]. FDA. 2020. Available from: https://www.fda.gov/media/144414/download. Cited 28 Dec 2020.
Finland reports first adverse reaction to Coronavirus vaccine [Internet]. Yle. 2021. Available from: https://yle.fi/uutiset/osasto/news/finland_reports_first_adverse_reaction_to_coronavirus_vaccine/11722156. Cited 3 Jan 2021.
WHO target product profiles for COVID-19 vaccines version 3–29 April 2020. WHO World Heal Organ. 2020, p. 1–7. https://www.who.int/publications/m/item/who-target-product-profiles-for-covid-19-vaccines.
Poland GA, Ovsyannikova IG, Crooke SN, Kennedy RB. SARS-CoV-2 vaccine development: current status. Mayo Clin Proc. 2020;95:2172–88. https://doi.org/10.1016/j.mayocp.2020.07.021.
Jarrett S, Yang L, Pagliusi S. Roadmap for strengthening the vaccine supply chain in emerging countries: manufacturers ’ perspectives. Vaccine. 2020;5:100068. https://doi.org/10.1016/j.jvacx.2020.100068.
Pagliusi S, Jarrett S, Hayman B, Kreysa U, Prasad SD, Reers M. Emerging manufacturers engagements in the COVID À 19 vaccine research, development and supply. Vaccine. 2020;38:5418–23.
GAVI—The Global Alliance for Vaccines and Immunizations [Internet]. WHO Glob. Heal. Work. Alliance. 2020. Available from: www.who.int/workforcealliance/members_partners/member_list/gavi/en/. Cited 23 Dec 2020.
Hwang A, Veira C, Malvolti S, Cherian T, Macdonald N, Steffen C, et al. Global vaccine action plan lessons learned II: stakeholder perspectives. Vaccine. 2020;38:5372–8. https://doi.org/10.1016/j.vaccine.2020.05.048.
Emergency Use Assessment and Listing Procedure (EUAL) for candidate vaccines for use in the context of a public health emergency [Internet]. WHO (World Health Organ. 2015. p. 1–10. Available from: https://www.who.int/medicines/news/EUAL-vaccines_7July2015_MS_(Updated_notes-disclaimers_21Aug2018).pdf?ua=1. Cited 14 Dec 2020.
Emergency use listing procedure for vaccines [Internet]. WHO (World Health Organ. 2020. Available from: https://www.who.int/teams/regulation-prequalification/eul/eulvaccines. Cited 14 Dec 2020.
Macdonald NE, Group W. Vaccine hesitancy: definition, scope and determinants. Vaccine. 2015;33:4161–4.
Reiter PL, Pennell ML, Katz ML. Acceptability of a COVID-19 vaccine among adults in the United States: how many people would get vaccinated ? Vaccine. 2021;38:6500–7. https://doi.org/10.1016/j.vaccine.2020.08.043.